Pre Conference Workshops

09:00 AM : 09:10 AM

Session 1

THEME AND TOPICS SPEAKERS ROLE
Welcome and Introductions Dr. Sukanya Choudhary
Executive VP
GSK Pharmaceuticals, India 		Speaker

09:10 AM : 09:25 AM

Session 1

THEME AND TOPICS SPEAKERS ROLE
Workshop Objectives and importance of Regulatory requirements in India Sneha Gupta
Associate Director, Regulatory Affairs
IQVIA 		Speaker

09:25 AM : 09:55 AM

Session 1

THEME AND TOPICS SPEAKERS ROLE
Sessoion : NDCTR 2019 Overview & Quiz Sneha Gupta
Associate Director, Regulatory Affairs
IQVIA 		Speaker

09:55 AM : 10:25 AM

Session 1

THEME AND TOPICS SPEAKERS ROLE
Group Exercise 1: Preparing and Reviewing Regulatory Dossiers to CDSCO - Case Studies with Presentation Vivek Padalalu
Associate Director, Site readiness and Regulatory Operations,
Fortrea 		Speaker
Mr. Sanjay Kabra
-
Independent Consultant 		Speaker

10:25 AM : 10:55 AM

TEA BREAK

10:55 AM : 12:10 PM

Session 2

THEME AND TOPICS SPEAKERS ROLE
Group Exercise 1 (Continued ): Preparing and Reviewing Regulatory Dossiers to CDSCOCase Studies with Presentation Vivek Padalalu
Associate Director, Site readiness and Regulatory Operations,
Fortrea 		Speaker
Mr. Sanjay Kabra
-
Independent Consultant 		Speaker

12:10 PM : 12:55 PM

Session 2

THEME AND TOPICS SPEAKERS ROLE
Session: Impact of ICH GCP E6 updates on sponsor decision making Dr. Narendra Maharaj
Vice President and Head, Clinical Development
Dr Reddy's Laboratories Ltd 		Speaker
Dr. Piyush Agarwal
Head Clinical Development, Global Clinical Management, IPDO
Dr Reddy's Laboratories Ltd 		Speaker

12:55 PM : 02:00 PM

Lunch Break

02:00 PM : 03:45 PM

Session 3

THEME AND TOPICS SPEAKERS ROLE
Group Exercise 2: Overview of Patient Safety parameters from an Ethics Committee perspective Mamta Sharma
Director Regulatory Affairs
Parexel International Pvt. Ltd 		Speaker
Anupam Bendre
Manager, Regulatory Affairs
GlaxoSmithKline Pharmaceuticals Ltd 		Speaker

03:45 PM : 04:45 PM

Session 4

THEME AND TOPICS SPEAKERS ROLE
Panel discussion: Driving Effective Regulatory Strategies Through Insights to NDCTR 2019 & ICH-GCP Sachin Satija
Sr. Director-Quality Assurance
Syneos Health 		Moderator
Dr. Shubhadeep D. Sinha
Industry: Senior VP
Hetero 		Panelist
Sudip Sinha
Senior Vice President, Operational Excellence and Quality
Let’s Evolve Life Pvt Ltd 		Panelist
Dr Usha Rani Pingali
Prof & HOD Pharmacology
Nizam's Institute of Medical Sciences 		Panelist
Dr. Rajeev Misra
Assistant Professor Department of Community Medicine and Public Health
KGMU, Lucknow 		Panelist

04:35 PM : 05:15 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
Session: ICH GCP Requirements and salient features of changes from R2 to R3 (draft): The How and Why Mr. Kedar Nayak
Study delivery lead team manager, Clinical Operations
GlaxoSmithKline Pharmaceuticals Ltd 		Speaker

05:15 PM : 05:20 PM

Session 6

THEME AND TOPICS SPEAKERS ROLE
Vote of Thanks Ganesh Boddu
Head – Regulatory Affairs & Clinical Research
Eris Lifesciences Ltd 		Speaker

08:00 AM : 09:00 AM

Registration

09:00 AM : 09:30 AM

Session 1

THEME AND TOPICS SPEAKERS ROLE
Introduction to workshop (overall flow of workshop) (introduction of faculty, mentors, icebreaker etc) Anushila Vaishali
Manager, Global Scientific Communication
Eli Lilly 		Speaker

09:30 AM : 09:45 AM

Session 2

THEME AND TOPICS SPEAKERS ROLE
Introducing to study Priti Pandey
Director – Biostatistics
Novartis Healthcare Pvt. Ltd. 		Speaker

09:45 AM : 10:45 AM

Session 3

THEME AND TOPICS SPEAKERS ROLE
Designing protocol key elements Ashish Adgaonkar
Expert Medical Writer, RWS GCO GDD
Novartis Healthcare Pvt. Ltd. 		Speaker

10:45 AM : 11:15 AM

Tea/Coffee Break

11:15 AM : 12:30 PM

Session 4

THEME AND TOPICS SPEAKERS ROLE
Data Management Key Elements - Datamanagement Plan, CRF design and edit checks and Validation Dr. Bishwapriya Deb
BDS, CCDM, Associate Director
Eli Lilly Services India Private Limited 		Speaker
Deven Babre
Consultant Life Science
- 		Speaker

12:30 PM : 01:15 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
SAP & TFLs Pramod Reddy
Head- Data Management and Biostatistics
Dr Reddy’s Laboratories Ltd 		Speaker

01:15 PM : 02:15 PM

Lunch Break

02:15 PM : 02:45 PM

Session 6

THEME AND TOPICS SPEAKERS ROLE
Cross-functional collaboration in CSR development Shravani Dudyala
Senior Regulatory Writer
Novartis Healthcare Pvt. Ltd. 		Speaker

02:45 PM : 03:00 PM

Session 7

THEME AND TOPICS SPEAKERS ROLE
Pre-post DBL activities Pattabhi Machiraju
Senior Director - Statistics COE, RWD & Clinical Development Solutions
Indegene Lifesystems Pvt. Ltd. 		Speaker

03:00 PM : 03:45 PM

Session 8

THEME AND TOPICS SPEAKERS ROLE
Partnering in study results interpretation Dr. Shima Shaikh (B.D.S)
Manager, Medical Writing Services India
Parexel International 		Speaker

03:45 PM : 04:15 PM

Tea/Coffee Break

04:15 PM : 04:55 PM

Session 9

THEME AND TOPICS SPEAKERS ROLE
Partnering in study results interpretation Priti Pandey
Director – Biostatistics
Novartis Healthcare Pvt. Ltd. 		Speaker

04:55 PM : 05:15 PM

Session 10

THEME AND TOPICS SPEAKERS ROLE
Collaboration across CDM-BIOS-MW Dr Hetal Shah
Founder-Director
MeWriT Healthcare Consulting 		Speaker
Sagar Kalantre
Associate Director Biometrics
Premier Research 		Speaker

05:15 PM : 05:30 PM

Session 10

THEME AND TOPICS SPEAKERS ROLE
Learning sharing and Closing remark (additional references) Gaurab Chakraborty
Senior Director
Fortrea 		Speaker

09:00 AM : 09:30 AM

Session 1

THEME AND TOPICS SPEAKERS ROLE
Inaugural Session Dr. Venkat Raman Kola
Clinical Director Dept of Critical Care Medicine
Yashoda Hospitals 		Speaker
Dr. Santosh Taur
Director Medical Affairs, Vaccines, Rare Disease & Digital
Pfizer 		Speaker
Kavitha Gurram
Director-Head of Project Management, Real World Solutions
IQVIA 		Speaker
Raviteja Adapa
Head- Clinical Operations
Syngene International Ltd. 		Speaker
Sudhakar Patil
Manager - Business Development
Clinion 		Speaker

09:30 AM : 10:15 AM

Session 1

THEME AND TOPICS SPEAKERS ROLE
Designing Registry Studies to Bridge the Evidence Gaps Ms. Chandana Pal
Manager, Clinical Research
Apollo Hyderabad 		Speaker
Raviteja Adapa
Head- Clinical Operations
Syngene International Ltd. 		Speaker

10:15 AM : 10:45 AM

Session 2

THEME AND TOPICS SPEAKERS ROLE
Conduct of Registry Studies: Regulatory and Ethics Perspectives Dr. Namrata Kulkarni
Medical Lead, Adult Vaccination
Pfizer Limited 		Speaker

10:45 AM : 11:00 AM

TEA BREAK

11:00 AM : 12:30 PM

Session 3

THEME AND TOPICS SPEAKERS ROLE
Group Exercise I Dr. Santosh Taur
Director Medical Affairs, Vaccines, Rare Disease & Digital
Pfizer 		Speaker
Kavitha Gurram
Director-Head of Project Management, Real World Solutions
IQVIA 		Speaker

12:30 PM : 01:30 PM

NETWORKING LUNCH BREAK

01:30 PM : 02:00 PM

Session 4

THEME AND TOPICS SPEAKERS ROLE
Navigating the Operational Challenges in Registry Studies Dr. Arvind Babu
In-Charge, Dept. of Clinical Research
Yashoda Hospital, Hyderabad 		Speaker
Dr. Alok Nachane
Director
VeritasQ Research and Analytics Pvt. Ltd. 		Speaker

02:00 PM : 02:30 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
Essentials of Product and Disease Registries Dr. Harshveer Malhi
Head, Medical Affairs, Oncology
Merck Group 		Speaker

02:30 PM : 03:00 PM

Session 6

THEME AND TOPICS SPEAKERS ROLE
Quality and Reporting of Registry Studies Dr. Arun Bhatt
Consultant
Clinical Research and Development 		Speaker

03:00 PM : 03:15 PM

HIGH TEA

03:15 PM : 04:15 PM

Session 7

THEME AND TOPICS SPEAKERS ROLE
Group Exercise II Dr. Santosh Taur
Director Medical Affairs, Vaccines, Rare Disease & Digital
Pfizer 		Speaker
Kavitha Gurram
Director-Head of Project Management, Real World Solutions
IQVIA 		Speaker

04:15 PM : 04:30 PM

Feedback and Conclusion

04:30 PM : 05:00 PM

WRAP UP AND CERTIFICATE DISTRIBUTION

08:00 AM : 09:00 AM

Registration

09:00 AM : 09:05 AM

Session 1

THEME AND TOPICS SPEAKERS ROLE
Welcome and Objectives of the workshop Anirban Roy Choudhury
AVP and Head global CoE for Data Management, Biostatistics and Clinical Operation
Sun Pharma 		Speaker

09:05 AM : 09:15 AM

Session 2

THEME AND TOPICS SPEAKERS ROLE
Opening Remarks Dr. Sarah McMullen
Country Director
USFDA 		Speaker

09:15 AM : 10:00 AM

Session 3

THEME AND TOPICS SPEAKERS ROLE
USFDA India Outlook & GCP Inspections Observations: Compliance Trends and Inspectional Resources (Multicentric CTs and BA/BE studies) Courtney Long
Consumer Safety Officer
USFDA 		Speaker
Phil Nguyen
Senior Assistant Country Director
USFDA 		Speaker
Alana Bias
Consumer Safety Officer
USFDA 		Speaker

10:00 AM : 11:00 AM

Session 4

THEME AND TOPICS SPEAKERS ROLE
Mirror Talk (15-20 mins each) Ensuring Participant Safety & Trial Integrity with Clinical Trials Oversight Dr Anvita Pandiya
Clinical Quality Auditor and Consultant
- 		Speaker
Dr Faraz Farishta
Director
CARE Hospitals PrivateLimited 		Speaker

11:00 AM : 11:30 AM

Session 6 Tea Break

12:30 PM : 01:00 PM

Session 7

THEME AND TOPICS SPEAKERS ROLE
Panel Discussion: How quality oversight is evolving with the changing landscape of clinical research in India? Anirban Roy Chowdhury
AVP and Head global CoE for Data Management, Biostatistics and Clinical Operation
Sun Pharma 		Moderator
Dr Neelakanth Krishnan
-
Dr. Reddy’s Laboratories 		Speaker
Prasad Shetty
"Senior Director & APAC Head Global Project Leadership, Internal Medicine"
IQVIA 		Speaker
Dr Raja Narayanan
-
Anant Bajaj Retina Institute 		Speaker

12:30 PM : 01:00 PM

Session 8

THEME AND TOPICS SPEAKERS ROLE
Understanding QbD in clinical trials and BA/BE studies Dr Anupama Ramkumar
Arkus Research Pvt Ltd
Principal Consultant & CEO 		Speaker

01:00 PM : 02:00 PM

Lunch Break

02:00 PM : 04:00 PM

Session 9

THEME AND TOPICS SPEAKERS ROLE
Case Study Sarah McMullen
Country Director
USFDA 		Speaker
Phil Nguyen
Senior Assistant Country Director
USFDA 		Speaker
Greg Smith
-
USFDA 		Speaker
Sudheendra Kulkarni
Medical Product Safety Coordinator – BIMO / Medical Devices
USFDA 		Speaker
Alana Bias
Consumer Safety Officer
USFDA 		Speaker
Courtney Long
Consumer Safety Officer
USFDA 		Speaker

03:30 PM : 04:00 PM

Tea Break

04:00 PM : 05:15 PM

Session 10

THEME AND TOPICS SPEAKERS ROLE
Case Study Sarah McMullen
Country Director
USFDA 		Speaker
Phil Nguyen
Senior Assistant Country Director
USFDA 		Speaker
Greg Smith
-
USFDA 		Speaker
Sudheendra Kulkarni
Medical Product Safety Coordinator – BIMO / Medical Devices
USFDA 		Speaker
Alana Bias
Consumer Safety Officer
USFDA 		Speaker
Courtney Long
Consumer Safety Officer
USFDA 		Speaker

05:15 PM : 05:30 PM

-

THEME AND TOPICS SPEAKERS ROLE
Closing Remarks Dr Anvita Pandiya
Clinical Quality Auditor and Consultant
- 		Speaker

10:00 AM : 10:30 AM

Session 1

THEME AND TOPICS SPEAKERS ROLE
Workshop Objectives and Goals Kirti Narang
Associate Director, Clinical Project Manager
IQVIA RDS India Pvt Ltd 		Speaker

10:30 AM : 11:20 AM

Session 2

THEME AND TOPICS SPEAKERS ROLE
Project Management Fundamentals Kirti Narang
Associate Director, Clinical Project Manager
IQVIA RDS India Pvt Ltd 		Speaker
Dr. Poonam Sule
Global Clinical Development, PHC,
Procter & Gamble Health Limited 		Speaker

11:20 AM : 11:40 AM

Tea Break

11:40 AM : 12:30 PM

Session 3

THEME AND TOPICS SPEAKERS ROLE
Project Scope Management Dr. Ankit Darji
Clinical Project Manager
IQVIA RDS India Pvt Ltd 		Speaker
Kirti Narang
Associate Director, Clinical Project Manager
IQVIA RDS India Pvt Ltd 		Speaker
Ms. Darshana Dholakia
Sr. CRM – GCO
Johnson and Johnson Innovative Medicine 		Speaker

12:30 PM : 01:30 PM

LUNCH BREAK

01:30 PM : 02:30 PM

Session 4

THEME AND TOPICS SPEAKERS ROLE
Financial Stewardship Dr. Shekhar Dawkhar
Senior Director, Enterprise Client Solutions,
Fortrea India 		Speaker
Ramya Basavaraju
Strategic Pricing Manager
Fortrea India 		Speaker
Srilakshmi Dhulipudi
Costing Manager
Fortrea India 		Speaker

02:30 PM : 03:20 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
Project Quality Management Sachin Mangelvedhkar
Vice President and Global Head - Clinical and PV QA
Glenmark 		Speaker
Mayur Khandelwal
Quality Manager, Clinical Operations Quality Management
IQVIA India 		Speaker
Sunny Omkar Singh
Senior Manager - Clinical Research
Eli Lilly (India) 		Speaker

03:20 PM : 03:40 PM

TEA BREAK

03:40 PM : 04:25 PM

Session 6

THEME AND TOPICS SPEAKERS ROLE
Stakeholder Management Ms. Arohee Ketkar
Senior Director and Head Clinical Leadership, Asia Pac
IQVIA (India) Pvt. Ltd. 		Speaker
Kirti Narang
Associate Director, Clinical Project Manager
IQVIA RDS India Pvt Ltd 		Speaker

04:25 PM : 05:15 PM

Session 7

THEME AND TOPICS SPEAKERS ROLE
Risk Management Deep Sharma
Senior Manager Clinical Operation,
TCS 		Speaker
Kirti Narang
Associate Director, Clinical Project Manager
IQVIA RDS India Pvt Ltd 		Speaker

05:15 PM : 05:30 PM

Session 8

THEME AND TOPICS SPEAKERS ROLE
What future hold on Clinical Project Management? Anirban Roy Choudhury
AVP and Head global CoE for Data Management, Biostatistics and Clinical Operation
Sun Pharma 		Speaker

Main Conference Tracks

08:00 AM : 11:00 AM

Registration/Tea/Coffee

09:00 AM : 12:30 PM

Session 1-3 Common Sessions Across All Tracks

12:30 PM : 01:30 PM

Lunch Break

01:30 PM : 03:00 PM

Session 4

THEME AND TOPICS SPEAKERS ROLE
Navigating the Evolving Regulatory Landscape: Challenges and Opportunities in Clinical Research in India Ms. Sukanya Choudhury
Executive Vice President – Regulatory Affairs
GSK 		Session Chair
Talk 1: Emerging Trends in Clinical Research – Is the Indian Regulatory Framework Future Ready ? Mr. A K Pradhan
Joint Drugs Controller (India)
CDSCO 		Speaker
Panel Discussion: Regulatory Reforms, Clinical Trial Approval Process, Data Privacy and Protection in clinical trials Dr. Shoibal Mukherjee
Director, Medical Research
Medanta Hospitals 		Moderator
Mr. A K Pradhan
Joint Drugs Controller (India)
CDSCO 		Panelist
Prof. D Raghunadharao
Professor of Medical Oncology
MNJ Institute of Oncology 		Panelist
Mr. Sanjay Vyas
EVP, Global SBU Head – Clinical Logistics & Safety Services and Managing Director, India
Parexel 		Panelist
Dr. Sadhna Joglekar
Senior Vice President and Head, Global Drug Development
Novartis 		Panelist
Ms. Varsha Rajesh
-
Nishith Desai Consultants 		Panelist
Audience Q&A

03:00 PM : 0

Session 5

THEME AND TOPICS SPEAKERS ROLE
Patient's perspective on clinical trials Dr. Kausik Maiti
Executive Director, Medical Sciences
Parexel International 		Session Chair & Moderator
Patient's perspective on clinical trials Dr. Annappa Kamath
Executive Director, Project Leadership
Parexel International 		Moderator
Ms. Shruti Chopra
Patient/Patient Advocate
Independent 		Panelist
Mr. Prasana Shirol
Patient Advocate
Independent 		Panelist
Dr. Udai Lal
Investigator: Director & Head, Internal Medicine
Aster Prime Hospital 		Panelist
Dr. Chinmoy K Bose
Investigator: Oncologist & SEC Member
N S C Bose Cancer Hospital, Kolkata 		Panelist
Audience Q&A

04:00 PM : 04:30 PM

Tea/Coffee Break

04:30 PM : 06:00 PM

Session 6

THEME AND TOPICS SPEAKERS ROLE
Challenges and Opportunities in Implementing AI & ML in conduct of Clinical Trials Mr. Mahesh Iyer
Head, Statistics, AI/ML, Quantitative & Digital Sciences, and Innovation, India & Philippines
Pfizer 		Session Chair
Talk 1: Generative AI for Clinical R & D Dr. Santosh Dixit
Chief Domain Expert -Innovation Labs
Persistent Systems 		Speaker
Clinical, Ethical and Regulatory considerations of AI/ML in clinical trials Mr. Mahesh Iyer
Head, Statistics, AI/ML, Quantitative & Digital Sciences, and Innovation, India & Philippines
Pfizer 		Moderator
Mr. Nataraj Kalyanaraman
Vice President, Head of drug development
BMS 		Panelist
Mr. Santosh Shevade
Consultant
Independent 		Panelist
Mr. Shobhit Shrotriya
Managing Director, Life Sciences R&D India
Accenture 		Panelist
Mr. Sridharan Sankaran
Principal Consultant, Head AI Ethics and Standards, R&I group
Tata Consultancy Services 		Panelist
Audience Q&A
Wrap Up for Day 1 Ms. Ami Shah
Director & Co-founder
SperaMed Consulting 		-

06:00 PM : 07:00 PM

Hall of Fame/Presidents Awards/Partner/LOC/SOC/Volunteers/ Felicitations

07:30 PM : 08:00 PM

Gala Dinner

01:30 PM : 03:00 PM

Session 4

THEME AND TOPICS SPEAKERS ROLE
Panel Discussion: Digital health technologies (DHT) and Decentralized Clinical Trails (DCT) Impact on Patient Outcomes Jeyaseelan Jeyaraj
Sr. Director, Health Sciences
Oracle 		Session Chair
Prathibha Prabhakaran
Associate Director, Clinical Data Science and Analytics
Eli Lilly 		Panelist
Namrataa Murthy
Executive Director, FSP Biometrics
Syneos 		Panelist
Kedar Deshmukh
Director, Clinical Data Science
ICON PLC 		Panelist
Kavita Rattan
Group Lead
Pfizer 		Panelist
Sarvesh Singh
APAC Regional Lead
PHUSE 		Panelist
Audience Q&A

03:00 PM : 04:00 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
TransCelerate DDF initiative on protocol digitization and eCTD Santosh Kumar
Vice-President - Clinical
Indegene 		Session Chair
Ayush Mittal
Co-Founder
Lifio 		Speaker
Mayank Bhatia
Sr.Consultant, Digital Data Flow Portfolio Head
TCS 		Speaker
Audience Q&A

04:00 PM : 04:30 PM

Tea/Coffee Break

04:30 PM : 06:00 PM

Session 6

THEME AND TOPICS SPEAKERS ROLE
Evolution of Clinical Data Review and Roles to Enhance Subject Safety outcomes Debjit Chakrabarti
Senior Director & Head of Centralized Monitoring FSP Services
IQVIA 		Session Chair
Suvarchala Nidhanapati
Clinical Data Scientist Lead - DM
ICON 		Speaker
Ms. Pradnya Avinash Kadam
Lead- Clinical Data Management
Eli Lilly India Private Limited 		Speaker
Dr.Rupali Bandekar
Head - Clinical Data Management
SIRO Clinpharm 		Speaker
Audience Q&A

06:00 PM : 07:00 PM

Hall of Fame/Presidents Awards/Partner/LOC/SOC/Volunteers/ Felicitations

07:30 PM : 08:00 PM

Gala Dinner

01:30 PM : 03:00 PM

Session 4

THEME AND TOPICS SPEAKERS ROLE
The Tale of Two Worlds : The Art and Science of Medical Writing and the technological innovations of AI Saurabh Singh
Senior Group Head, Regulatory Writing and Submissions
Novartis 		Session Chair
Is the hype real? Real-life user experience of a medical writing AI tool for CSR production Lisa Chamberlain James
Senior Partner
Trilogy Writing & Consulting 		Speaker
Automation, standardization, and simplification in CSR patient narratives preparation Sudhir Inumarthi
Senior Regulatory Writer-Manager
Novartis 		Speaker
Revolutionizing content creation: Structured content authoring with generative AI Ritesh Dogra
AVP - Medical Tech Commercialization
Indegene 		Speaker
Audience Q&A
A world in turmoil- Losing the art and science of medical writing in the world of AI and technological innovation! Animesh Chatruvedi
Head, Regulatory Writing and Submissions
Novartis 		Moderator
Saurabh Singh
Senior Group Head, Regulatory Writing and Submissions
Novartis 		Panelist
Soma Das
Senior Manager
Fortrea Scientific Services Private Limited, Mumbai 		Panelist
Sonal More
Product Manager, TCS ADD Platform
Tata Consultancy Services 		Panelist
Madhuri T
Manager, Global Scientific Communication
Eli Lilly 		Panelist

03:00 PM : 04:00 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
The New Era of Drug Approval for Innovative Therapies Salman Mohammad
Associate Director Clinical Regulatory Writing
Astra Zeneca 		Session Chair
Prototyping: A way forward in building submissions Debraj Saha
Manager II, Clinical Regulatory Writing
AstraZeneca 		Speaker
Overview of FDA and EMA expedited drug development approval programs Vandana Kuna
Principal Medical Writer
Parexel 		Speaker
Tea/Coffee Break

04:00 PM : 04:30 PM

Tea/Coffee Break

04:30 PM : 06:00 PM

Session 6

THEME AND TOPICS SPEAKERS ROLE
The New Era of Drug Approval for Innovative Therapies Salman Mohammad
Associate Director Clinical Regulatory Writing
Astra Zeneca 		Session Chair
Harmonization of safety reporting for medical writing: Bridging the gap between FDA, EMA, and other regulatory authorities Nalin Taneja
Senior Manager, Medical Writing
Parexel 		Speaker
Audience Q&A (include questions from Sesseion 5)
Challenges and opportunities to prepare high quality documents for accelerated and non-accelerated submissions Salman Mohammad
Associate Director Clinical Regulatory Writing
Astra Zeneca 		Moderator
Geetha R
Group Lead, Global Scientific Communication
Eli Lilly 		Panelist
Nomita Saxena
Senior Director, Clinical Regulatory Writing
Astra Zeneca 		Panelist
Marianne Pederson
Sr. Director GRSD, Regulatory Sciences
BMS 		Panelist
Sathyanarayanan Muthusamy
Manager, Medical Writing
Novo Nordisk 		Panelist
Shruthi Reddy
Group Head, Regulatory Writing and Submissions
Novartis 		Panelist
Wrap Up for Day 1 Garima Pallavi
Senior Director, Medical Writing Services
Parexel 		Speaker

06:00 PM : 07:00 PM

Hall of Fame/Presidents Awards/Partner/LOC/SOC/Volunteers/ Felicitations

07:30 PM : 08:00 PM

Gala Dinner

01:30 PM : 03:00 PM

Session 4

THEME AND TOPICS SPEAKERS ROLE
Opportunities/Challenges of using different technologies like R in regulatory Submissions Soumitra Kar
Lead Statistician
Novo Nordisk 		Session Chair
A real world insight and navigation on bridging FDA submission using R Soumitra Kar
Lead Statistician
Novo Nordisk 		Speaker
Mahendran Venkatachalam
Statistical Programming Specialist
Novo Nordisk 		Speaker
Package in CRAN : {admiralvaccine} Dhivya Kanagaraj
Manager, Statistical Data Sciences Lead
Pfizer 		Speaker
Arjun Rubalingam
Associate Statistical Data Scientist
Pfizer Limited 		Speaker
Traverse the 'PHARMAVERSE' : ouR insights Pooja Kumari
Lead Programmer
GSK 		Speaker
Audience Q&A

03:00 PM : 04:00 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
Panel Discussion: Optimizing Clinical Research through effective collaboration between Statisticians and Statistical Programmers Hanumantha Rao Karedla
Head - Oncology Data Analytics
Bayer 		Moderator
Panel Discussion: Optimizing Clinical Research through effective collaboration between Statisticians and Statistical Programmers Dr Nirali Mehta
Founder & CEO
Pharma-Stats 		Panelist
Ayan Das Gupta
Director, Biostatistics
Novartis 		Panelist
Sangeetha Loganathan
Senior Director, Statistical Programming
Parexel International 		Panelist
Gargi Paigaonkar
Head, Clinical & Statistical Programming
Johnson & Johnson 		Panelist
Audience Q&A

04:00 PM : 04:30 PM

Tea/Coffee Break

04:30 PM : 06:00 PM

Session 6

THEME AND TOPICS SPEAKERS ROLE
Enhancing Clinical Research through Effective data visualization and analysis Anik Chatterjee
Head, Statistical Programming, India
Merck KGaA 		Session Chair
Enhancing Clinical Research through Effective data visualization and analysis Anik Chatterjee
Head, Statistical Programming, India
Merck KGaA 		Speaker
“Picture -Perfect”- Some Distinctive Visualization Techniques in Clinical Trials Supratik Chakraborty
Principal Biostatistician
ICON 		Speaker
Effective Data Visualisation for Outlier Detection in Clinical Trials Prajnya Srinivas
Analyst
Eli Lilly 		Speaker
Srinidhi Ramachandran
Analyst
Eli Lilly 		Speaker
Audience Q&A

06:00 PM : 07:00 PM

President's and Hall of fame awards distribution

07:30 PM : 08:00 PM

Gala Dinner

01:30 PM : 03:00 PM

Session 4

THEME AND TOPICS SPEAKERS ROLE
KEYNOTE: Real World and Safety Data Analysis – Recent Advancements in Technology Dr J Vijay Venkatraman
Managing Director & CEO
Oviya Medsafe 		Session Chair
Mr. Aman Wasan
CEO
ArisGlobal 		Speaker
Evolving Regulatory Landscape in Pharmaco- and Materio-vigilance Dr. Debashis Bisoi
Assistant Professor, Dept of Pharmacology
AIIMS Bibinagar, Telangana 		Speaker
Panel Discussion: Materiovigilance : Current Trends & Road Ahead – Panel ( ) Ms. Indu Nambiar
Local Patient Safety Lead
Boehringer Ingelheim India Pvt. Ltd. 		Moderator
Dr. Debashis Bisoi
Assistant Professor, Dept of Pharmacology
AIIMS Bibinagar, Telangana 		Panelist
Dr. Jamal Baig
Multi Country Safety Head
Sanofi 		Panelist
Dr Siva Kumar Buddha
Director - Head Signal and Risk Management
Indegene 		Panelist
Ms.Hina Talwar
Safety Services Project Leader
Parexel International 		Panelist
Audience Q&A

03:00 PM : 04:00 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
Title: RWE for Health Technology Assessment Dr. Santosh Taur
Director Medical Affairs, Vaccines, Rare Disease & Digital
Pfizer 		Session Chair
Leveraging real-world evidence for health technology assessment – Using big data to enable patient access Dr. Jackie Vanderpuye Orgle
Vice President, Global Head Advanced Analytics (HEOR & RWE)
Parexel International, USA 		Speaker
Utility of Real-World Evidence in Health Technology Assessment: HTAIn Perspective Dr Beena Joshi
Scientist, & Head of Department, Operational & Implementation Research
" ICMR National Institute for Research in Reproductive and Child Health, Mumbai" 		Speaker
Audience Q&A

04:00 PM : 04:30 PM

Tea/Coffee Break

04:30 PM : 06:00 PM

Session 6

THEME AND TOPICS SPEAKERS ROLE
Integrated Evidence Generation Dr. Namrata K
Medical Lead, Adult Vaccination
Pfizer Ltd 		Session Chair & Moderator
Real-World Evidence and Clinical Decision Making in Oncology Dr MVT Krishna Mohan
Senior Consultant Medical Oncologist
Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad. 		Speaker
My Journey of Real-World Evidence Generation in Diabetes Mellitus Dr K Neelaveni
Professor & Head of Dept., Endocrinology
Osmania Medical College & Osmania General Hospital, Hyderabad 		Speaker
Impact of Real-World Evidence in Pulmonology Practice Dr Ashfaque Hasan
Principal and Professor of Pulmonology
Deccan College of Medical Sciences, Hyderabad 		Speaker
Panel Discussion: Integrated Evidence Generation Across the Product Lifecycle Dr. Namrata Kulkarni
Medical Lead, Adult Vaccination
Pfizer Limited 		Moderator
Dr Ashfaque Hasan
Principal and Professor of Pulmonology
Deccan College of Medical Sciences, Hyderabad 		Speaker
Dr Chirag Trivedi
Global Head, Clinical Study Unit, Early Operational Strategy (Clinical Development)
Sanofi 		Speaker
Dr MVT Krishna Mohan
Senior Consultant Medical Oncologist
Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad. 		Speaker
Dr K Neelaveni
Professor & Head of Dept., Endocrinology
Osmania Medical College & Osmania General Hospital, Hyderabad 		Speaker
Audience Q&A

06:00 PM : 07:00 PM

Hall of Fame/Presidents Awards/Partner/LOC/SOC/Volunteers/ Felicitations

07:30 PM : 08:00 PM

Gala Dinner

08:00 AM : 09:00 AM

Registration/Tea/Coffee

09:00 AM : 12:30 PM

Session 1-3 Common Sessions Across All Tracks

12:00 PM : 01:30 PM

Lunch Break

01:30 PM : 03:00 PM

Session 4

THEME AND TOPICS SPEAKERS ROLE
Healthcare Innovations Ecosystem Current Scenario and Wishlist Dr. Ajit Nair
"Head- Regulatory Sciences Global Regulatory Sciences (GRS)"
Bristol Myers Squibb 		Session Chair & Moderator
Dr. Murali Ramachandra
CEO
Aurigene Oncolog 		Panelist
Dr. V. Ramprasad
CEO
MedGenome 		Panelist
Mr. Jayant Karve
Founder and Director
RCupe Lifesciences Pvt. Ltd 		Panelist
Mr. Somnath Basu
Scientist E/ Former DDCI CDSCO
AMTZ, Vishakhapatnam Andhra Pradesh 		Panelist
Audience Q&A

03:00 PM : 04:00 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
Preclinical to Clinical Translation : Strategies for Successful Bench to Bedside Translation Dr. Shridhar Narayanan
CEO
Foundation for Neglected Disease Research, Bengaluru, Karnataka, India 		Speaker
Audience Q&A

04:00 PM : 04:30 PM

Tea/Coffee Break

04:30 PM : 06:00 PM

Session 6

THEME AND TOPICS SPEAKERS ROLE
Ethics, Affordability, and Strategies to Improve Cell and Gene Therapy for Patients Amita Bhave
Director Regulatory Affairs, Global Drug Development India
Novartis Healthcare Pvt Ltd 		Session Chair & Moderator
Dr. Geeta Jotwani
Senior Deputy Director General & Scientist 'G' · 
Indian Council of Medical Research (ICMR) 		Panelist
Ms Annam Visala
Deputy Drug Controller (India)
CDSCO, New Delhi 		Panelist
Dr. Sheffali Gulati
Chief, Child Neurology Division, Department of Pediatrics
AIIMS 		Panelist
Dr. Vikram Mathews
Director
CMC Vellore 		Panelist
Audience Q&A
Wrap Up for Day 1 Nanjaraje Urs
CEO
Clinoquent 		-

06:00 PM : 07:00 PM

Hall of Fame/Presidents Awards/Partner/LOC/SOC/Volunteers/ Felicitations

07:30 PM : 08:00 PM

Gala Dinner

Main Conference Tracks

09:00 AM : 10:30 AM

Session 7

THEME AND TOPICS SPEAKERS ROLE
Future Landscape of Clinical Trials in India & its Impact on Patient Outcomes Dr. Arun Maseeh
Senior Medical Director, Medical & Scientific Management Clinical Development
Syneos Health 		Session Chair
Talk 1: Sites collaborating efficiently with Industry - (future) Mr Allan Bukuya
Managing Director
TrialDocs International Pty Ltd 		Speaker
Talk 2: Decentralized clinical trials: How relevant for India Dr. Chinmoy K Bose
Investigator: Oncologist & SEC Member
N S C Bose Cancer Hospital, Kolkata 		Speaker
Panel discussion: How to bring and scale-up clinical trial innovation in India? Dr. Maya Sharma
VP Clinical, regulatory & Pharmacovigilance
Novo Nordisk 		Moderator
Dr. Andrey Vasilenko
Director-Clinical Development Centre India
Novo Nordisk India Pvt Ltd. 		Panelist
Dr. Kaustuv Sen
Director-Project Delivery, Neurosciences
Thermo Fisher Scientific 		Panelist
Mr. Rishi Kapur
Director Regulatory Affairs & Patient Safety
AstraZeneca Pharma India Ltd 		Panelist
Dr. Venkat Rangam
Director
Medclinica CRO 		Panelist
Ms. Asha Nair
Director-Site Solutions
Premier Research Group India Pvt. Ltd. 		Panelist
Mr. Navneet Pratap Singh
Deputy Drugs Controller (India)
CDSCO 		Panelist
Dr. Partha Banerjee
Director- Clinical Development
Novartis 		Panelist
Audience Q&A

10:30 AM : 11:00 AM

Tea/Coffee Break

11:00 AM : 12:30 PM

Session 8

THEME AND TOPICS SPEAKERS ROLE
Project Mgt 2.0: Leading the Future of Clinical Trials Mr. Kedar Nayak
Study delivery lead team manager, Clinical Operations
GlaxoSmithKline Pharmaceuticals Ltd 		Session Chair & Moderator
Real life Case Scenarios 1 Rakesh Kumar
Study Director, Global Clinical Operations
Novartis 		Speaker
Real life Case Scenarios 2 Sheetal Verlekar
Associate Asset Lead, Vx global Clinical Delivery
GSK 		Speaker
Being Future Ready  – Transformation from being “Project” Managers to “Program” leaders and achieve excellence in program delivery Dr Chirag Trivedi
Global Head, Clinical Study Unit, Early Operational Strategy (Clinical Development)
Sanofi 		Panelist
Dr. Seema Pai
Director, Clinical Site Operations – India Cluster
Pfizer 		Panelist
Mr. Prasad Shetty
Senior Director & APAC Head, Global Project Leadership- Internal Medicine
IQVIA 		Panelist
Dr. Shekhar Dawkhar
Senior Director, Enterprise Client Solutions,
Fortrea India 		Panelist
Suraj Ravindran
Senior Director Global Data Strategy & Management Service Delivery, Global Clinical Operations
GSK 		Panelist
Audience Q&A

12:30 PM : 02:00 PM

Lunch Break

02:00 PM : 03:00 PM

Session 9

THEME AND TOPICS SPEAKERS ROLE
Ethics, Compliance  & Patient Diversity in clinical trials Dr. Nandini K Kumar
President , former Deputy Director General Sr. Grade (ICMR)
Forum for Ethics Review Committees in India 		Session Chair
WHO Benchmark Tools for Ethics Committees Dr. Nandini K Kumar
President , former Deputy Director General Sr. Grade (ICMR)
Forum for Ethics Review Committees in India 		Speaker
A Dialogue: Risk Based Quality Management Ms. Priti Balkrishna Namdhari
Manager, Centralized Monitoring Unit-Bangalore
Novo Nordisk 		Panelist
Ms. Lakshmi Achuta
Principal Strategic Advisor - Biotech, Pharmaceuticals & Medical Devices
AshRin bio 		Panelist
Dr. Bikash Medhi
Prof. Dept. of Pharmacology
PGIMER 		Panelist
Audience Q&A

03:00 PM : 04:30 PM

Session 10

THEME AND TOPICS SPEAKERS ROLE
Empowering Patients, Enhancing Outcomes: Unlocking the potential of Patient Centricity in Clinical Trials Dr. Usharani Pingali
Prof & HOD Pharmacology
Nizams Instt of Medical Sciences, Hyderabad 		Session Chair
How can patients and general public benefit from the Clinical Trial Registry India (CTRI)? Dr. Gaurav Mathur
Senior Director Regulatory Affairs
Parexel International 		Moderator
Ms. Tulsi Adhikari
Scientist F, Coordinator CTRI
National Institute of Medical Statistics (NIMS), ICMR) 		Panelist
Mrs. Ratnakumari
EC Lay Person/People representative
NIMS Stem Cell EC 		Panelist
Is digitization helping drive Patient Centricity and Improve Patient Outcomes? Ms. Arohee Ketkar
Senior Director and Head Clinical Leadership, Asia Pac
IQVIA (India) Pvt. Ltd. 		Moderator
Mr. Sujit Nair
Senior Director, Strategic Operations
IQVIA 		Panelist
Dr. Sandesh Sawant
Vice President Medical Affairs, Head-Clinical Trials, Chair, ISCR Investigator council
Cipla Ltd 		Panelist
Ms. Darshana Dholakia
Sr. CRM – GCO
Johnson and Johnson Innovative Medicine 		Panelist
Dr. Srikanth Krishnamurthy
Consultant pulmonologist, Head department of clinical research
Institute of lung care and research, Hindusthan hospital, Coimbatore 		Panelist
Mr. Somaiah Muckatira
Head- Regulatory affairs & Pharmacovigilance
Novo Nordisk 		Panelist
Audience Q&A
Conference Wrap-up Ms. Ami Shah
Director & Co-founder
SperaMed Consulting 		-
Mr. Sanjay Kabra
-
Independent Consultant 		-

09:00 AM : 10:30 AM

Session 7

THEME AND TOPICS SPEAKERS ROLE
Synergizing Systems: Impact and Integration in EDC Development with Other Tools Pramod Reddy
Head- Data Management and Biostatistics
Dr Reddy’s Laboratories Ltd 		Session Chair
Manuj Vangipurapu
Chief Executive Officer
Clinion IT Services 		Panelist
Abhishek Ghosh
Clinical Research & Project Management Professional
Member of PMI, ISCR, SCDM & PHUSE India Volunteer 		Panelist
Ms. Varsha Patel
Data Acquisition Expert
Johnson & Johnson 		Panelist

10:30 AM : 11:00 AM

Tea/Coffee Break

11:00 AM : 12:30 PM

Session 8

THEME AND TOPICS SPEAKERS ROLE
Panel Discussion: Digital Transformation of Clinical Trials – Are we thinking about the patients yet? Sathyavathy Ramanathan
Senior Director - CDM
Fortrea 		Moderator
Bhairavi Bhinde
Director, Clinical Operations, India Local Solutions
IQVIA 		Panelist
Abby Abraham
Global Head Data Science, & Country Head
George Clinical 		Panelist
Deepa Desai
Founder & CEO
D Cube Consultancy 		Panelist
Jagadeesh Rudraswamymath
Global Head, Clinical Data Operations
Novartis 		Panelist
Siddesh MV
Practice Head- CDM
PARADIGM IT 		Panelist
Audience Q&A

12:30 PM : 02:00 PM

LUNCH BREAK

02:00 PM : 03:00 PM

Session 9

THEME AND TOPICS SPEAKERS ROLE
Innovation of using synthetic data Bhaskar Subramanian
Director - Statistical Data Sciences & Analytics
Pfizer 		Moderator
Neeta Mukesh Das
Associate Manager - CDM
Parexel International 		Speaker
Aparajeeta Priyadarasini
Manager, Solution Consulting
Medidata 		Speaker
Audience Q&A

03:00 PM : 04:30 PM

Session 10

THEME AND TOPICS SPEAKERS ROLE
Demystifying the Clinical Data Science Puzzle: All you need to know about Appalla Prabhakar
Group Head, Clinical Data Acquisition Management
Novartis 		Session Chair
Suraj Ravindran
Senior Director Global Data Strategy & Management Service Delivery, Global Clinical Operations
GSK 		Speaker
Shalima james
Clinical data science lead
ICON 		Speaker
Vinodh Kumarjestadi
Associate Director - Clinical Programming
Astrazeneca 		Speaker
Audience Q&A
Conference Wrap-up

09:00 AM : 10:30 AM

Session 7

THEME AND TOPICS SPEAKERS ROLE
The Multi-Faceted Domain of Medical Writing Natasha Das
Cofounder and Director
Hazlo Consultancy 		Session Chair
The spectrum of medical communications through the writers' lens Pooja Banerjee
Director, Medical Services & Delivery
IJCP Group 		Speaker
Latest trends in medical publications and medical communication Natasha Das
Cofounder and Director
Hazlo Consultancy 		Speaker
Transitioning between Regulatory writing and Medical communication Neelam Joglekar
Manager, Medical Writing
Fortrea Scientific Services Private Limited, Mumbai 		Moderator
Chinmayee Joshi
Manager, Medical Writing
Fortrea Scientific Services 		Panelist
Ambika Subramanian
Director, Scientific Writing
Actu-Real Inc. 		Panelist
Anita Bhat
Director-Medical
Medulla Communications 		Panelist
Jai Tilak Jain
Associate Director
Syneos Health 		Panelist
Ashish Adgaonkar
Expert Medical Writer, RWS GCO GDD
Novartis Healthcare Pvt. Ltd. 		Panelist

10:30 AM : 11:00 AM

Tea/Coffee Break

11:00 AM : 12:30 PM

Session 8

THEME AND TOPICS SPEAKERS ROLE
The Transformative Tool called “Technical Leadership” in Medical Writing Dr. Julia Forjanic Klapproth
Senior Partner
Trilogy Writing & Consulting 		Session Chair
Continued professional development as a medical writer: One size does not fit all! Hetal Shah
Founder-Director
MeWriT 		Speaker
Expertise and proficiency in diverse domain of medical writing Ankita Kashyap
Senior Manager, Safety Medical Writing
Parexel 		Speaker
Technical Leadership: Shaping future of medical writing in India Anushila Vaishali
Manager, Global Scientific Communication
Eli Lilly 		Moderator
Shalini Dwivedi
VP, Head of Medical Writing and Clinical Trial Transparency
Krystelis 		Panelist
Garima Pallavi
Senior Director, Medical Writing Services
Parexel 		Panelist
Ankit Shah
Regulatory Capability Lead, Global Scientific Communications
Eli Lilly 		Panelist
Dr. Julia Forjanic Klapproth
Senior Partner
Trilogy Writing & Consulting 		Panelist

12:30 PM : 02:00 PM

Lunch Break

02:00 PM : 03:00 PM

Session 9

THEME AND TOPICS SPEAKERS ROLE
Guidelines that Transformed the Way we Write Jai Tilak Jain
Associate Director
Syneos Health 		Session Chair
Overview of ICH M11 guidelines, possible revisions, and path ahead to protocol digitization Jai Tilak Jain
Associate Director
Syneos Health 		Speaker
Navigating through updates and preparing regulatory documents in compliance with EU Clinical Trial Regulation Raina Agarwal
Associate Director, Clinical Trial Transparency
MMSHoldings 		Speaker
Resuming EMA Policy 0070: Data transparency submission insights and lessons learned Shivangi Shrivastava
Transperency Manager
Novartis 		Speaker

03:00 PM : 04:30 PM

Session 10

THEME AND TOPICS SPEAKERS ROLE
Patient Engagement through Medical Writing Soma Das
Senior Manager
Fortrea Scientific Services Private Limited, Mumbai 		Session Chair
Key considerations in the development of informed consent forms for gene therapy trials Vidya Shetty
Medical Writer
Parexel 		Speaker
Examining the role of effective product information labeling in enhancing patient outcomes and well-being Priyanka Kumari
Senior Manager, Regulatory Writing
Indegene 		Speaker
My health, My words! Patient engagement in clinical publications Debasri Mukherjee
Senior medical writer
Fortrea Scientific Services Private Limited, Mumbai 		Speaker
Enabler to a successful publication: Well-crafted response to reviewer comments Prajakta Nachane
Manager, Medical Writing
Fortrea Scientific Services 		Speaker
Audience Q&A
Conference Wrap-up Garima Pallavi
Senior Director, Medical Writing Services
Parexel 		-

09:00 AM : 10:30 AM

Session 7

THEME AND TOPICS SPEAKERS ROLE
Evolving Data standards in clinical research - Standards Implementation & Submission Ruchi Prakash Sahu
Expert Statistical Analyst
Bayer 		Session Chair
Harivardhan Uppula
Lead Statistical Analyst
Bayer 		Session Chair
Unlocking the Answers: Metadata Submission Guidelines (SDTM-MSG ) Ruchi Prakash Sahu
Expert Statistical Analyst
Bayer 		Speaker
Harivardhan Uppula
Lead Statistical Analyst
Bayer 		Speaker
Automation of SDTM using MINT and OAK Rathan Kumar Rangu
Principal Stat Programmer
Syneos Health 		Speaker
Linga Reddy Aenugu
Associate Director, Statistical Programming
Syneos Health 		Speaker
Navigating the Complexity of Clinical Laboratory Data: Challenges and Solutions for Programmers Sandeep Kumar Meneni
Principal statistical Programmer
Novartis 		Speaker
Padmini Thatavarthi
Statistical Programmer
Novartis 		Speaker

10:30 AM : 11:00 AM

Tea/Coffee Break

11:00 AM : 12:30 PM

Session 8

THEME AND TOPICS SPEAKERS ROLE
Can new technologies (AI/ML/IOT) a threat or blessing for Biostatisticians and Statistical Programmers? Smitha Nalam
Director, Statistical Programming
ICON Plc 		Moderator
Venkata Sureshbabu Bondu
Director, Clinical Solutions
BMS 		Panelist
VM Sreedevi Menon
Associate Director, Biometrics
Caidya 		Panelist
Divya Kanniah
Senior Data Scientist – Products
Symbiance 		Panelist
Jeba Kumar
Director & Head Statistical Data Sciences & Analytics – Standards and Submissions
Pfizer Limited 		Panelist

12:30 PM : 02:00 PM

Lunch Break

02:00 PM : 03:30 PM

Session 9

THEME AND TOPICS SPEAKERS ROLE
Statistical Approaches in Clinical Trial Design (like Estimands) Mahendra Bijarnia
Sr. Director, Statistics
AstraZeneca 		Session Chair
Navigating the Estimand Landscape: Selecting the Right Estimand for Clinical Trials Dr. Ginto Jacob Pottackal
Principal Statistical Scientist
PPD 		Speaker
Augmenting Randomized Control Arm Using Synthetic Control Arm Saswat Mohapatra
Senior Statistical Programmer
AstraZeneca 		Speaker
Bayesian logistic regression model for risk prediction in chronic disease Dr. Supriya Khare
Senior Biostats Specialist
Fortrea 		Speaker
Audience Q&A

03:30 PM : 04:30 PM

Session 10

THEME AND TOPICS SPEAKERS ROLE
Scientific Innovations in clinical research through case studies - Real time scenarios using new statistical methodologies and programming techniques Krishnendu Biswas
Senior Group Head, Statistical Programming
Novartis 		Session Chair
Novel approaches to calculate the DLTs and MTDs in Clinical trials Shipra Das Gupta
Lead Statistical Programmer
Bayer 		Speaker
Long-Term and Very-Long-Term Disease Control in Patients From BYLieve Study Cohort A Yogesh Chattar
Senior Biostatistician
Novartis 		Speaker
Audience Q&A
Conference Wrap-up Gaurab Chakraborty
Senior Director
Fortrea 		-

09:00 AM : 10:30 AM

Session 7

THEME AND TOPICS SPEAKERS ROLE
Potential of RWD to Generate Quality Evidence Dr. Pramod Gawli
Medical Director
Fortrea Development India Pvt. Ltd. 		Session Chair & Moderator
Quality in RWE: Design and Conduct of the ‘fit-for-purpose’ Studies Dr. Arun Bhatt
Consultant
Clinical Research and Development 		Speaker
Balancing Novelty and Quality of RWD Sources Mr. Hitesh Bharucha
Associate Director
Eversana 		Speaker
Panel Discussion: Potential of RWD/RWE to Generate Quality Evidence Dr. Arun D Bhatt
Consultant – Clinical Research & Drug Development
Independent 		Panelist
Ms Kavitha Gurram
Director, Head of Project Management
IQVIA 		Panelist
Dr. Alok Nachane
Director
VeritasQ Research and Analytics Pvt. Ltd. 		Panelist
Dr. Pramod Gawli
Medical Director
Fortrea Development India Pvt. Ltd. 		Moderator
Mr. Ram Prasanna
Director, RWE
Eversana 		Panelist

10:30 AM : 11:00 AM

Tea/Coffee Break

11:00 AM : 12:30 PM

Session 8

THEME AND TOPICS SPEAKERS ROLE
Emerging Trends in Health Economics & Outcomes Research (HEOR) Dr. Rishabh Pandey
Director & Regional Delivery Head – HEOR
Parexel International 		Session Chair & Moderator
Panel Discussion: Role and Use of Composite Outcomes in Health Economics Outcomes Research Dr. Rito Bergemann
VP, Global Head HEOR
Parexel 		Panelist
Mr. Jitender Takyar
Director
HEOR Parexel Access Consulting. 		Moderator
Dr Rajalakshmi M
Manager Medical Affairs
Syngene 		Panelist
Dr Santosh Tiwari
Director - Health Economics (GHEOR Lead)
Teva Pharmaceuticals 		Panelist
Talk 1: Leveraging HEOR data for implementation of VBHC in India: Challenges and recommendations Ms. Saipriya J
Consultant Health Economics
Parexel 		Speaker
Audience Q&A

12:30 PM : 02:00 PM

LUNCH BREAK + POSTER PRESENTATIONS

02:00 PM : 03:00 PM

Session 9

THEME AND TOPICS SPEAKERS ROLE
Technology in Pharmacovigilance Dr. Babita Kirodia
Country Pharmacovigilance Lead at Amgen Technology
Amgen 		Session Chair
NDCT 2019 Overview & SAE reporitng via SUGAM - Regulatory Expectatons Dr. Babita Kirodia
Country Pharmacovigilance Lead at Amgen Technology
Amgen 		Speaker
Dr Sable
DDC(I)
CDSCO 		Speaker

03:00 PM : 04:30 PM

Session 10

THEME AND TOPICS SPEAKERS ROLE
Harnessing Technologies to Navigate the RWE Landscape Dr. Puja Nagpal
Head Basic Research Lab
Indian Spinal Injuries Center, New Delhi 		Session Chair
Technology to improve Data Quality and Ease of Conducting RWE Dr. Harshveer Malhi
Head, Medical Affairs, Oncology
Merck Group 		Speaker
Gains and Pitfalls of AI/ML in Real-World Evidence Dr. Suresh Munuswamy
Deputy Director, Health Informatics and Technology Innovations, PHFI
Additional Professor, Indian Institute of Public Health-Hyderabad (IIPH-H) 		Speaker
Panel Discussio:n: Harnessing Technologies to Navigate the RWE Landscape in India Dr. Puja Nagpal
Head Basic Research Lab
Indian Spinal Injuries Center, New Delhi 		Moderator
Dr. Harshveer Singh Malhi
Head Medical Affairs, Oncology
Merck 		Panelist
Dr. Suresh Munuswamy
Deputy Director, Health Informatics and Technology Innovations, PHFI
Additional Professor, Indian Institute of Public Health-Hyderabad (IIPH-H) 		Panelist
Ms Shruti MP
Director, Real World Data Solutions
Parexel 		Panelist
Dr. Jeyaseelan Jeyaraj
Senior Director, Life Sciences, Asia Pacific
Oracle 		Panelist

09:00 AM : 10:30 AM

Session 7

THEME AND TOPICS SPEAKERS ROLE
Introduction to ISCR ACCRI (10 Mins) Dr. Ananya Chakraborty
Prof & HOD Pharmacology
Vydehi Institute Of Medical Sciences And Research Centre, Bangalore 		Session Chair
Innovations in Academic Clinical Research for Better Patient Care Dr. Sundeep Lakhtakia
MD MNAMS DM FSGEI FASGE FACG FJGES Director, Endoscopy & EUS
Asian Institute of Gastroenterology (AIG) Hospitals 		Speaker
Engaging stakeholder to deliver Innovations in academic clinical research for better patient care Dr. Ananya Chakraborty
Prof & HOD Pharmacology
Vydehi Institute Of Medical Sciences And Research Centre, Bangalore 		Moderator
Dr. Sanish Davis
R&D Director, Global Clinical Operations, India
Janssen 		Panelist
Mr. Somnath Basu
Scientist E/ Former DDCI CDSCO
AMTZ, Vishakhapatnam Andhra Pradesh 		Panelist
Dr. Usharani Pingali
Prof & HOD Pharmacology
Nizams Instt of Medical Sciences, Hyderabad 		Panelist
Dr. Denis Xavier
Professor & Head Pharmacology, Head -Div of Clinical Research
St. John's Medical College Bangalore 		Panelist
Dr. Faraz Farishta
Director
CARE Hospitals PrivateLimited 		Panelist
Audience Q&A

10:30 AM : 11:00 AM

Tea/Coffee Break

11:00 AM : 12:30 PM

Session 8

THEME AND TOPICS SPEAKERS ROLE
Strengthening early phase clinical trials in academia Dr. Amitava Ray
CEO/Founder
Exsegen 		Speaker
Dr T. Gangadhar
Professor of Nephrology
Nizam's Institute of Medical Sciences 		Speaker
Dr. Ramesh Jagannathan
VP- Medical Affairs
BSV 		Session Chair
ISCR’s National Award for Excellence in Academic Clinical Research- Short presentations
Audience Q&A

12:30 PM : 02:00 PM

Lunch Break

02:00 PM : 03:00 PM

Session 9

THEME AND TOPICS SPEAKERS ROLE
ISCR’s National Award for Excellence in Academic Clinical Research- Short presentations
Followed by 4th ISCR-ACCRI National Awards for Excellence in Academic Clinical Research 2023
Wrap up -ISCR ACCRI Dr. Ananya Chakraborty
Prof & HOD Pharmacology
Vydehi Institute Of Medical Sciences And Research Centre, Bangalore 		Session Chair

03:00 PM : 04:30 PM

Session 10

THEME AND TOPICS SPEAKERS ROLE
Artificial Intelligence Accelerating Drug Development (AIDD) Dr Vaibhav Salvi
Director & Head Clinical Study Unit, India and Southeast Asia R&D Clinical Sciences & Operations
Sanofi 		Session Chair
AI based Target Discovery Prof. Vinod PK
Associate Professor
International Institute of Information Technology, Hyderabad 		Speaker
Topic 2 Computer Aided Drug Design Prof. Dr. Vasundhra Bhandari
Assistant Professor
National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad 		Speaker
Topic 3 AI based De-novo Drug Design Dr. Rajgopal Srinivasan
Chief Scientist and Head – Life Sciences Research Area
TCS Research & Innovation, Hyderabad 		Speaker
Topic 4 Success stories for AI/ML in drug discovery Venkat Narayanan
Co-founder
Peptris 		Speaker
Topic 5 Success Stories and Future Challenges Dr Vaibhav Salvi
Director & Head Clinical Study Unit, India and Southeast Asia R&D Clinical Sciences & Operations
Sanofi 		Speaker
Audience Q&A
CONFERENCE WRAP - UP Dr. Rajani Menon
Project Director
Syneos Helath 		-